Developing a Biomarker for Monitoring Clinical Outcomes in Children With Spinal Lipoma.

NCT02722681 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-03-30

No results posted yet for this study

Summary

'Spinal lipoma' is a condition, present from before birth, in which fatty tissue (lipoma) is attached to the lower end of the spinal cord, tethering it within the vertebral canal. The cord normally moves up and down with respiration, whereas tethering prevents this movement, and can lead to progressive neurological deterioration. The cord and spinal nerves become stretched and their blood supply is damaged irreversibly. Disability may include weakness or pain in the lower body, and urinary disorders in young children. Treatment is surgical, to remove the lipoma and mobilise the spinal cord, with 60 such operations performed per year at Great Ormond Street Hospital. This project aims to develop lipidomic biomarkers in order to predict which children with spinal lipoma are at highest risk of neurological deterioration, and require early surgery, while providing evidence to adopt a more conservative approach for those at lower risk.

Conditions

  • Lipoma of Spinal Cord

Interventions

PROCEDURE

Blood and urine sampling

Collection of blood and urine samples taken during usual clinical management

PROCEDURE

Cerebrospinal fluid sampling

Collection of cerebrospinal fluid samples taken during usual clinical management

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER
  • Institute of Child Health

    lead OTHER

Principal Investigators

  • Andrew Copp, PhD · Institute of Child Health, UCL

  • Dominic Thompson, FRCS · Great Ormond Street Hospital NHS Trust

  • Kevin Mills, PhD · Institute of Child Health, UCL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722681 on ClinicalTrials.gov